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This study was a randomized, double-blind, multi-center phase III clinical trial to evaluate the event-free survival (EFS) of Adebrelimab with S-1 and oxaliplatin versus placebo combined with S-1 and oxaliplatin, and to evaluate the efficacy, safety and tolerability of the two combination regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: Adebrelimab with SOX. | Experimental |
| |
| Treatment group B: placebo with SOX. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab plus S-1 and oxaliplatin | Drug | Adebrelimab plus S-1 and oxaliplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed EFS | Assessments BY INVESTIGATORS | About 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (pCR) rate as assessed by the Pathology Review Committee (PRC) | Complete remission (pCR) rates after surgery | About 3 years |
| Rate of pathologically significant response (MPR) as assessed by the Pathology Review Committee (PRC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Bai | Contact | +0518-81220121 | bin.bai@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 10000 | China |
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| Adebrelimab blank preparation plus S-1 and oxaliplatin. | Drug | Adebrelimab blank preparation plus S-1 and oxaliplatin. |
|
Pathologically significant response (MPR) rate after surgery
| About 3 years |
| EFS as assessed by an independent review committee (IRC) | Independent Review Committee (IRC) evaluation | About 8 years |
| DFS, as assessed by investigator /IRC | Investigator /IRC assessment | About 8 years |
| pCR rate by central pathological evaluation | Central pathological evaluation was studied | About 3 years |
| R0 resection rate of neoadjuvant therapy evaluated by investigators in different treatment groups | Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator | About 8 years |
| D2 radical resection rate of neoadjuvant therapy evaluated by investigators in different treatment groups | Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator | About 8 years |
| objective response rate (ORR) of neoadjuvant therapy evaluated by investigators in different treatment groups | Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator | About 8 years |
| The incidence of adverse events (AE) were evaluated according to NCI-CTCAE 6.0 | NCI-CTCAE 6.0 was used for evaluation | About 4 years |
| The severity of serious adverse events (SAE) were evaluated according to NCI-CTCAE 6.0 | NCI-CTCAE 6.0 was used for evaluation | About 4 years |
| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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